FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
81337–81360 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 01, 2000
ULTRASOUND SCANNER, TYPE 1101
K002085 · IYO
B & K Medical A/S
Radiology · 22d
Cleared Aug 01, 2000
SONOACE SA 9900 DIAGNOSTIC ULTRASOUND SYSTEM
K002185 · IYN
Medison America, Inc.
Radiology · 13d
Cleared Aug 01, 2000
EXPLORER CVS TRANSCRANIAL DOPPLER
K990517 · IYN
Diagnostic Medical Systems
Radiology · 530d
Cleared Aug 01, 2000
CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM
K992905 · JEY
Codman & Shurtleff, Inc.
Dental · 337d
Cleared Aug 01, 2000
ADVANTIS ASC INFUSION PUMP AND ADMINISTRATION SETS
K993524 · FRN
Alaris Medical Systems, Inc.
General Hospital · 288d
Cleared Jul 31, 2000
PATHWAY CTS 2000 PELVIC FLOOR TRAINING SYSTEM, MODEL PATHWAY CTS 2000
K001515 · KPI
The Prometheus Group
Gastroenterology & Urology · 76d
Cleared Jul 31, 2000
SURGIFLATOR-40
K001533 · HIF
W.O.M. Gmhb
Obstetrics & Gynecology · 75d
Cleared Jul 31, 2000
RENU MULTIPLUS MULTI-PURPOSE SOLUTION
K001539 · LPN
Bausch & Lomb, Inc.
Ophthalmic · 75d
Cleared Jul 31, 2000
PROTECTIV SAFETY BLOOD COLLECTION NEEDLE
K001690 · FMI
Johnson & Johnson Medical, Inc.
General Hospital · 59d
Cleared Jul 31, 2000
DC TITAN
K001798 · EJH
Austenal, Inc.
Dental · 47d
Cleared Jul 31, 2000
LIFESTYLES, CONTEMPO OR PRIVATE LABEL LARGE CONDOM
K001883 · HIS
Ansell Healthcare, Inc.
Obstetrics & Gynecology · 40d
Cleared Jul 31, 2000
ANGIODYNAMICS ABSCESSION BILIARY DRAINAGE CATHETER
K002101 · FGE
AngioDynamics, Inc.
Gastroenterology & Urology · 49d
Cleared Jul 31, 2000
NON-STERILE POWDER FREE BUBBLE-GUM SCENTED LATEX EXAMINATION GLOVE WITH...
K002175 · LYY
Sgmp Co., Ltd.
General Hospital · 12d
Cleared Jul 31, 2000
NON-STERILE POWDER FREE PINEAPPLE SCENTED LATEX EXAMINATION GLOVES WITH...
K002176 · LYY
Sgmp Co., Ltd.
General Hospital · 12d
Cleared Jul 31, 2000
ADVANCED UROSCIENCE INJECTION NEEDLE
K002323 · FBK
Advanced Uroscience, Inc.
Gastroenterology & Urology · 34d
Cleared Jul 28, 2000
BIOCUFF, MODELS 225718, 225728, 225736, 235718, 235728, 235736
K001378 · MAI
Bionx Implants, Inc.
Orthopedic · 88d
Cleared Jul 28, 2000
DATA MASTER PERFUSION MONITORING SYSTEM
K001388 · DRY
Dideco
Cardiovascular · 87d
Cleared Jul 28, 2000
HEMOSAFE PATIENT CONNECTOR FOR FRESENIUS BLOODLINES, MODEL 04-9100-0
K001873 · FJK
Fresenius Medical Care North America
Gastroenterology & Urology · 38d
Cleared Jul 28, 2000
COLLEAGUE CX VOLUMETRIC INFUSION PUMP 2M8161 AND VOLUMETERIC INFUSION PUMP...
K002211 · FRN
Baxter Healthcare Corp
General Hospital · 7d
Cleared Jul 28, 2000
SYNTHES BIORESORBABLE SUTURE ANCHOR
K994161 · MAI
Synthes (Usa)
Orthopedic · 232d
Cleared Jul 27, 2000
TOP QUALITY CHLORINATED-POWDERFREE EXAMINATION GLOVES
K000050 · LYY
Top Quality Mfg., Inc.
General Hospital · 202d
Cleared Jul 27, 2000
CARDIOVISE ECG INTERPRETATIVE SOFTWARE
K001349 · MWJ
Inovise Medical, Inc.
Cardiovascular · 90d
Cleared Jul 27, 2000
E-Z LINK CROSS CONNECTOR
K001372 · KWP
Depuyacromed
Orthopedic · 87d
Cleared Jul 27, 2000
PATIENT MATCHED COBALT ALLOY TROCHLEA REPLACEMENT
K001374 · KRR
Biomet Manufacturing, Inc.
Orthopedic · 87d